External infusion device with remote programming, bolus estimator and/or vibration alarm capabilities

ABSTRACT

An infusion system for infusing a liquid into a body includes an external infusion device and a remote commander. The external infusion device includes a housing, a receiver, a processor and an indication device. The receiver is coupled to the housing and for receiving remotely generated commands. The processor is coupled to the housing and the receiver to receive remotely generated commands and to control the external infusion device in accordance with the commands. The indication device indicates when a command has been received and indicates when the command is being utilized to control the external infusion device so that the external infusion device is capable of being concealed from view when being remotely commanded. The remote commander includes a commander housing, a keypad for transmitting commands, and a transmitter for transmitting commands to the receiver of the external infusion device.

RELATED APPLICATIONS

[0001] This application claims priority on U.S. Provisional PatentApplication Serial No. 60/096,994filed on Aug. 18, 1998, which is hereinspecifically incorporated by reference.

FIELD OF THE INVENTION

[0002] This invention relates to external infusion devices and, inparticular embodiments, to a medication infusion device that includesthe capability to be remotely controlled, a bolus estimator to determinethe dosage to be administered by the infusion device, and a vibrationalarm.

BACKGROUND OF THE INVENTION

[0003] Insulin must be provided to people with Type I and many with TypeII diabetes. Traditionally, since it cannot be taken orally, insulin hasbeen injected with a syringe. More recently, use of external infusionpump therapy has been increasing, especially for delivering insulin fordiabetics using devices worn on a belt, in a pocket, or the like, withthe insulin delivered via a catheter with a percutaneous needle orcannula placed in the subcutaneous tissue. For example, as of 1995, lessthan 5% of Type I diabetics in the United States were using pumptherapy. There are now about 7% of the currently over 900,000 Type Idiabetics in the U.S. using insulin pump therapy, and the percentage isnow growing at an absolute rate of over 2% each year. Moreover, thenumber of Type I diabetics is growing at 3% or more per year. Inaddition, growing numbers of insulin using Type II diabetics are alsousing external insulin infusion pumps. Physicians have recognized thatcontinuous infusion provides greater control of a diabetic's condition,and are also increasingly prescribing it for patients. In addition,medication pump therapy is becoming more important for the treatment andcontrol of other medical conditions, such as pulmonary hypertension, HIVand cancer. Although offering control, pump therapy can suffer fromseveral complications that make use of a pump less desirable for theuser.

[0004] One drawback is the inability to conceal an external infusionpump and catheter tubing from view. Many users desire to hide theexternal pump under clothing so as not to seem different from normalpeople. However, this is inconvenient or impractical, especially fordiseases such as diabetes, since a user must have ready access to theexternal pump for monitoring or administering extra amounts ofmedication (i.e., boluses during the course of the day). If a user hasconcealed the external pump, the user must partially undress orcarefully maneuver the external pump to a location that permits accessto the display and keypad.

[0005] A further drawback is the inability to limit the access of theuser to certain capabilities. For instance, the user should have accessto the keypad so that the user can change the values and parameters ofdaily pump operation. However, there may be certain parameters that theuser should not have access to. This can be especially important, whenthe pump is being used by children or the elderly. However, if access isvery limited, a user may even have to go to the factory and/or to thephysician to have the parameters changed.

[0006] Another drawback for diabetic pump users, in particular, is thedetermination of the amount of bolus insulin to be delivered for a mealso as to avoid high blood sugars that would otherwise be caused by themeal. This can be a difficult calculation using formulas andapproximations that have several variables that must be measured andcalculated. Often, it is easier, but not the best for control, for theuser to simply guess what they need rather than to calculate the actualamount of the bolus needed to adequately cover the carbohydrates beingconsumed. However, in worse case scenarios, guessing can lead to underor overdosing of medication, sometimes with dire consequences.

[0007] Another drawback to using an infusion pump, is the step ofpriming the external infusion pump to remove gas bubbles in thereservoir and/or tubing. The user must first manually shake thereservoir to move any bubbles to the distal end of the reservoir. Thenthe user must carefully expel the bubbles through the tubing. However,unless all bubbles are moved to the distal end of the reservoir, theuser will have to expel a larger amount of medication, which can bewasteful, and very costly for special types of medications, such asthose used in HIV and cancer treatment. Improved methods of priming theexternal infusion pump are needed.

SUMMARY OF THE DISCLOSURE

[0008] It is an object of an embodiment of the present invention toprovide an improved external infusion device, which obviates forpractical purposes, the above mentioned limitations.

[0009] According to an embodiment of the invention, an external infusiondevice for infusion of a liquid into a body includes a housing, areceiver, a processor and indication device. The receiver is coupled tothe housing for receiving remotely generated commands. The processor iscoupled to the housing and the receiver to receive remotely generatedcommands and to control the external infusion device in accordance withthe commands. The indication device indicates when a command has beenreceived and indicates when the command is being utilized to control theexternal infusion device. In this way, the external infusion device canbe operated when concealed from view by being remotely commanded.

[0010] Further embodiments include a memory for storing programs, andthe receiver is capable of receiving software updates and facilitatingremote programming of external infusion device capabilities. Inaddition, the memory may store patient infusion history and pumpactivity. Also, the remotely generated commands may be capable ofprogramming and activating an audio (or vibratory) bolus delivery of theliquid by the external infusion device, a temporary basal rate deliveryof the liquid by the external infusion device, of suspending delivery ofthe liquid by the external infusion device, an extended bolus (such as asquare wave bolus or profiled bolus) delivery of the liquid by theexternal infusion device, and a dual wave bolus delivery of the liquidby the external infusion device.

[0011] In particular embodiments, an infusion system for infusing aliquid into a body includes an external infusion device and a remotecommander. The external infusion device includes a housing, a receiver,a processor and an indication device. The receiver is coupled to thehousing for receiving remotely generated commands. The processor iscoupled to the housing and the receiver to receive remotely generatedcommands to control the external infusion device in accordance with thecommands. The indication device indicates when a command has beenreceived and indicates when the command is being utilized to control theexternal infusion device so that the external infusion device is capableof being concealed from view when being remotely commanded. The remotecommander includes a commander housing, a keypad for transmittingcommands, and a transmitter for transmitting commands to the receiver ofthe external infusion device.

[0012] In particular embodiments, the remote commander is sized to fiton a key ring. Also, the remote commander may use RF frequencies,optical frequencies, IR frequencies, ultrasonic frequencies, magneticeffects, or the like, to transmit remote commands to the externalinfusion device. In addition, the remote commander is capable ofproviding remote commands at a distance greater than 1 inch.Furthermore, the processor of the external infusion device has a uniqueidentification code, and the remote commander includes the capability toread and learn the unique identification code of the external infusiondevice. Alternatively, the user can program in the unique identificationcode. The remote commander and the external infusion device use a uniqueidentification code to substantially avoid interference with otherexternal infusion devices.

[0013] In still other embodiments, the remote commander includes a modethat permits physician controlled programming of specific capabilitiesof the external infusion device to the exclusion of the user, and theremote commander may also include a link to a computer to allowprogramming to initiate or alter available capabilities of the externalinfusion device. Also, the external infusion device may include a memoryfor storing programs, and the receiver is capable of receiving softwareupdates and facilitating remote programming of external infusion devicecapabilities. In addition, the memory may store patient infusion historyand pump activity. Finally, the remote commander may be capable ofreceiving data from another medical device and providing the receiveddata to the external infusion device and/or remotely commanding andcontrolling another medical device. Other embodiments of the remotecommander may also display the data.

[0014] In further preferred embodiments, an external infusion device forinfusion of a liquid into a body includes a housing, a processor, abolus estimator and an indication device. The bolus estimator used inconjunction with the processor and externally supplied values willestimate an amount of liquid to be infused based upon an estimate of amaterial to be taken in by the body. The indication device is used toindicate when an amount of fluid to be infused has been estimated. Inaddition, the bolus estimator includes the capability to estimate acorrection bolus based upon a current characteristic value and a targetcharacteristic value and/or a liquid sensitivity that is used todetermine the amount of liquid to be infused so as to estimate thecorrection bolus. Further, embodiments of the bolus estimator include alockout to prevent the calculation of a bolus for a predetermined periodof time after a bolus has been estimated by the bolus estimator. Otherembodiments include a duration factor to account for how long apreviously infused amount of liquid will remain active in the body, andto adjust the estimate accordingly. In preferred embodiments, the liquidto be infused is insulin, and the material to be taken in iscarbohydrates. Also, codes representing the carbohydrate levels ofspecific foods or meals may be used as the externally supplied values.

[0015] In yet another embodiment, an external infusion device forinfusion of a liquid into a body includes a housing containing areservoir, a processor and a vibration device. The processor is coupledto the housing. The vibration device is used in conjunction with theprocessor to provide an alarm, and to generate sufficient vibration toassist in removing gas bubbles from the fluid in the reservoir duringpriming of the external infusion device. In further embodiments, thevibration device is used to agitate the fluid in the reservoir inbetween periodic deliveries of the fluid by the external infusion deviceand/or during delivery of the fluid by the external infusion device.

[0016] In other embodiments, an external infusion device for infusion ofa liquid into a body includes a housing containing a reservoir, aprocessor, an audible alarm and a vibration device. The processor iscoupled to the housing, and the audible alarm. The vibration device isused in conjunction with the processor and the audible alarm to providean alarm. In further embodiments, the vibration device is also used toagitate the fluid in the reservoir in between periodic deliveries of thefluid by the external infusion device and/or during delivery of thefluid by the external infusion device. In particular embodiments, theprocessor selects to activate one of the audible alarm and vibrationalarm independently of the unselected alarm.

[0017] In still yet another embodiment, an external infusion device forinfusion of a liquid into a body includes a housing, a processor, akeypad and an indication device. The processor is coupled to thehousing, and the keypad is coupled to the housing and used inconjunction with the processor to determine an estimate of remainingbattery power. The indication device indicates an estimate of remainingbattery power.

[0018] In still further embodiments, an external infusion device forinfusion of a liquid into a body includes a housing, a processor, amemory, a keypad and an indication device. The processor is coupled tothe housing, and the memory is coupled to and used in conjunction withthe processor to store at least two personal delivery patterns. Thekeypad is also coupled to the housing and used in conjunction with theprocessor to select one of the at least two personal delivery patterns,and the indication device indicates the selected personal deliverypattern. In preferred embodiments, the processor controls the externalinfusion device in accordance with the selected one of the at least twopersonal delivery patterns.

[0019] In further embodiments, an external infusion device for infusionof a liquid into a body includes a housing, a processor, a memory, akeypad and an indication device. The processor is coupled to thehousing, and the memory is coupled to and used in conjunction with theprocessor to store at least two basal rate profiles. The keypad is alsocoupled to the housing and used in conjunction with the processor toprogram the at least two basal rate profiles, and the indication deviceindicates the basal rate profile during programming. In preferredembodiments, the processor controls the external infusion device inaccordance with the programmed at least basal rate profiles.

[0020] In yet further embodiments. an external infusion device forinfusion of a liquid into a body includes a housing, a processor, amemory, a keypad and an indication device. The processor is coupled tothe housing, and the memory is coupled to and used in conjunction withthe processor to store at least two bolus types. The keypad is alsocoupled to the housing and used in conjunction with the processor toselect one of the at least two bolus types, and the indication deviceindicates the selected bolus type. In preferred embodiments, theprocessor controls the external infusion device in accordance with theselected one of the at least two bolus types.

[0021] In yet still further embodiments, an external infusion device forinfusion of a liquid into a body includes a housing, a receiver,processor, memory and an indication device. The receiver is coupled tothe housing for receiving remotely generated commands. The processor iscoupled to the housing and the memory device. The memory is used inconjunction with the processor to store at least two personal deliverypatterns, and the processor is coupled to the receiver to receive theremotely generated commands and to control the external infusion devicein accordance with the commands to select one of the at least twopersonal delivery patterns. The indication device is used to indicatethe selected personal delivery pattern and when a command has beenreceived to control the external infusion device in accordance with theselected personal delivery pattern such that the external infusiondevice is capable of being concealed from view when being remotelycommanded. Also, the processor controls the external infusion device inaccordance with the selected one of the at least two personal deliverypatterns.

[0022] Other features and advantages of the invention will becomeapparent from the following detailed description, taken in conjunctionwith the accompanying drawings which illustrate, by way of example,various features of embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0023] A detailed description of embodiments of the invention will bemade with reference to the accompanying drawings, wherein like numeralsdesignate corresponding parts in the several figures.

[0024]FIG. 1 is a simplified block diagram of an external infusiondevice and system in accordance with an embodiment of the presentinvention.

[0025]FIG. 2 is a perspective view of an external infusion device andsystem in accordance with an embodiment of the present invention.

[0026]FIG. 3 is a top perspective view of an RF programmer in accordancewith an embodiment of the present invention.

[0027]FIG. 4 is a top perspective view of a remote commander inaccordance with another embodiment of the present invention.

[0028]FIG. 5 is a front plan view of an LCD display for use in anembodiment of the present invention.

[0029]FIG. 6 is a table of Setup II options used on external infusiondevices in accordance with embodiments of the present invention.

[0030]FIG. 7 is a flow diagram illustrating the steps used to set abolus with and without the carbohydrate estimator in accordance withembodiments of the present invention.

[0031] FIGS. 8(a) and 8(b) are flow diagrams illustrating the steps usedto access the features of the setup II menu options shown in FIG. 6.

[0032]FIG. 9 is a table of the main menu options used on externalinfusion devices in accordance with embodiments of the presentinvention.

[0033]FIG. 10 is a table of Setup I menu options used on externalinfusion devices in accordance with embodiments of the presentinvention.

[0034]FIG. 11 is a flow diagram illustrating the steps used to accessthe main menu options shown in FIG. 9.

[0035]FIG. 12 is a flow diagram illustrating the steps used to accessthe features of the setup I menu options shown in FIG. 10.

[0036]FIG. 13 is a graph showing units delivered versus expected days ofoperation on a set of batteries.

[0037]FIG. 14 is a chart illustrating factory default setting used byembodiments of the present invention.

[0038]FIG. 15 is a simplified diagram of an external infusion device andsystem in accordance with another embodiment of the present invention.

[0039]FIG. 16 is a simplified block diagram of an external infusiondevice and system in accordance with still another embodiment of thepresent invention.

[0040]FIG. 17 is a simplified block diagram of an external infusiondevice and system in accordance with yet another embodiment of thepresent invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0041] As shown in the drawings for purposes of illustration, theinvention is embodied in an external infusion device for infusion of aliquid, such as medication, chemicals, enzymes, antigens, hormones,vitamins or the like, into a body of a user. In preferred embodiments ofthe present invention, the external infusion device is an externalinfusion pump, which includes an RF programming capability, acarbohydrate (or bolus) estimation capability and/or vibration alarmcapability. Particular embodiments are directed towards use in humans;however, in alternative embodiments, the external infusion devices maybe used in animals.

[0042] As illustrated in FIG. 1, preferred embodiments of the externalinfusion device 10 include a remote RF programmer 12, a carbohydrate (orbolus) estimator 14 and/or a vibration alarm 16. The RF programmer 12and carbohydrate estimator 14 communicate with a processor 18 containedin a housing 20 of the external infusion device 10. The processor 18 isused to run programs and control the external infusion device 10, and isconnected to an internal memory device 22 that stores programs,historical data, user defined information and parameters. In preferredembodiments, the memory device is a Flash memory and SRAM; however, inalternative embodiments, the memory device 22 may include other memorystorage devices such as ROM, DRAM, RAM, EPROM, dynamic storage such asother flash memory, energy efficient hard-drive, or the like. Inpreferred embodiments, the external infusion device 10 is an externalinfusion pump that is programmed through a keypad 24 on the housing 20or by commands received from the RF programmer 12 through atransmitter/receiver 26. Feedback from the external infusion device 10on status or programming changes are displayed on an LCD 28 and/oraudibly through a speaker 30. In alternative embodiments, the keypad 24may be omitted and the LCD 28 may be used as a touch screen input deviceor the keypad 24 may utilize more keys or different key arrangementsthen those illustrated in the figures. The processor 18 is also coupledto a drive mechanism 32 that is connected to a fluid reservoir 34containing fluid that is expelled through an outlet 36 in the reservoir34 and housing 20, and then into a body of a user through tubing and aset 38. In further alternative embodiments, the keypad 24, LCD 20,speaker 24 may be omitted from the external infusion device, and allprogramming and data transfer is handled through the RF programmer 12.

[0043] Generally, as shown in FIG. 2, preferred embodiments of theexternal infusion device 10 are an external insulin pump having thecapability to deliver 0 to 35 Units/hour in basal rates and up to 25.0Units per meal bolus of U-100 Insulin. In alternative embodiments, theexternal pump delivers other concentrations of insulin, or otherliquids, and may use other limits on the delivery rate.

[0044] The external infusion device 10 will also give the user thechoice of an audible alarm and/or vibration alarm 16 such as of awarning that is indicative of a low reservoir situation or low batteryor some malfunction of the system, such as an occlusion of the outletthat restricts the delivery of the fluid. Alarms may start out at a lowlevel and escalate until acknowledged by the user. In furtherembodiments, both an audible alarm and a vibration alarm may be given atthe same time.

[0045] As shown in FIG. 5, embodiments of the external infusion device10 will utilize a segmented screen LCD 28 that offers multiple languagecapability in approximately 6 languages. However, alternativeembodiments may include larger or smaller language capabilities. Furtheralternative embodiments, may utilize an LCD that uses a dot matrix,active matrix or the like. A scratch resistant window may be utilized toprovide improved durability, better viewing and less glare.

[0046] Several programming options will be available in the externalinfusion device 10, and will include at least two customized basalprofiles, a carbohydrate (or bolus) estimator 14 and an alarm clock, aswell as remote and on-device programming. Additionally, aphysician/educator will be able to configure the external infusiondevice 10 through a Communications Station (Communication-Station—shownin FIG. 15) to provide or restrict access to certain programmingoptions. Particular embodiments of the external infusion device 10 willalso download stored information through the Communication-Station.Further description of a Communication Station of this general type isbe found in U.S. Pat.. No. 5,376,070 to Purvis et al., entitled DATATRANSFER SYSTEM FOR AN INFUSION PUMP, which is herein incorporated byreference. This information can be used alone or combined withinformation from a Glucose Meter and/or a Glucose Sensor (not shown) toassist the user and/or the health care professional in makingintelligent therapy decisions. Moreover, the information, programs anddata may be downloaded to a remote or local PC, laptop,Communication-Station, or the like. for analysis and review by a MiniMedor a trained health care professional through the transmitter/receiver26. The data may also be downloaded through a Communication-Station 8 toa remotely located computer 6 such as a PC, laptop, or the like, overcommunication lines 7, by modem or wireless connection, as shown in FIG.15.

[0047] The external infusion device 10 will also have additional memorycapacity to allow configuring of the display during manufacturing todisplay information in several different foreign languages, and allowfor filter upgrades and revisions without the requirement of a hardwarechange. For example, a PC program will enable manufacturing to selectthe language for the pump. Languages are contingent upon availablespace, but will include English, French, Spanish, Italian, Dutch,Swedish and German. In alternative embodiments, other languages will bedetermined based upon space availability.

[0048] RF Programmer

[0049] The remote RF programmer 12 (or remote commander) will enable theuser to perform basic external infusion device 10 programming stepswithout accessing the keyboard 24 on the external infusion device 10 orlooking at the LCD (Liquid Crystal Display) 28 screen. This will benefitvisually impaired users of the external infusion device 10, since theremote RF programmer 12 will give them ready access to the most commonlyused operations of the external infusion device 10, and will obviate theneed for visual feedback. Of particular importance to the sight impairedwill be the auditory feedback (and/or vibration feedback as discussedbelow) that the external infusion device 10 will provide. Theinstructions from the RF programmer 12 will be confirmed by a series ofaudible beeps (or if requested by programming, vibration) from theexternal infusion device 10. In alternative embodiments, the RFprogrammer 12 may include a receiver and provide an audio (or vibration)indication that the commands have been received and acknowledged by theexternal infusion device 10. In further embodiments, the keypad 102 onthe remote RF programmer 12 will have the letters defining thecapability of the key encoded in Braille, and the ridges that orient theuser to the keypad 102 will be quite pronounced to assist in guiding theuser to the proper function key. Other embodiments may utilize keys thathave different sizes or shapes to further enhance the ability for usersto identify the correct buttons to activate the various features andfunctions.

[0050] A remote RF programmer 12 will provide convenience and discretionfor the user of the external infusion device 10 by allowing concealmentof the external infusion device 10 under clothes, in pouches, or thelike. Preferably, the RF programmer 12 is an optional accessory item onthe external infusion device 10, and the external infusion device 10will be fully functional without the use of the RF programmer 12.However, in alternative embodiments, the keypad 24 in the externalinfusion device 10 may be omitted and all programming would be handledby a local or remote PC, laptop, Communication-Station, RF programmer orthe like. In preferred embodiments, the RF programmer 12 will alsoprovide the user with the ability to perform the following functions:deliver a bolts, suspend/restart the external infusion device, and setand cancel a temporary basal rate. However, in alternative embodiments,the RF programmer may include still additional capabilities such as datatransfer (e.g., external infusion device history data or data from othermedical devices), updates to software and programming, or the like. Inpreferred embodiments, the data transfer capabilities between the RFprogrammer 12 and the transmitter/receiver 26 of the external infusiondevice 10 are two-way. In alternative embodiments, the data transferfrom the RF programmer 12 to the external infusion device 10 is one-way,such that the RF programmer 12 does not receive transmissions from theexternal infusion device 10. In further embodiments, the RF programmeracts as a relay, or shuttle, for data transmission between the externalinfusion device 10 and a PC, laptop, Communication-station, or the like.

[0051] In addition, as shown in FIG. 16, a relay or repeater 4 may beused with an external infusion device 10 and an RF programmer 12 toincrease the distance from which the RF programmer 12 can be used withthe external infusion device 10. For example, the relay could be used toprovide information to parents of children using the external infusiondevice 10 and allow them to program the external infusion device 10 froma distance with the RF programmer 12. The information could be used whenchildren are in another room during sleep or doing activities in alocation remote from the parents. In further embodiments, the relay 4can include the capability to sound an alarm. In addition, the relay 4may be capable of providing external infusion device 10 information to aremotely located individual via a modem connected to the relay 4 fordisplay on a monitor, pager or the like. In a still further embodimentof the present invention, the external infusion device 10 is capable ofbeing programmed by multiple RF programmers 12, as shown in FIG. 17. Forinstance, each RF programmer 12 would learn (or be programmed with) theunique code (discussed below) of the external infusion device 10. Thiswould be useful for users that desired to have multiple RF programmers12, such as at home, office and/or school or needed a replacement for anRF programmer that was lost.

[0052] In preferred embodiments, the RF programmer 12 is similar inappearance to the type of remote that is used to lock and unlock cardoors. It will have four (4) keys on a keypad 102 on a housing 104,which will be laid out in a square grid pattern, similar in appearanceand layout to the keypad 24 on the external infusion device 10, as shownin FIGS. 2 and 3. In alternative embodiments, fewer keys may be used tosimplify the RF programmer 12 (see FIG. 15), reduce manufacturing costsand/or to reduce the number of program capabilities available (such asSuspend (S), bolus (B), or the like). Preferably, the RF programmer 12should include a ring 106 that fits on a key ring to lessen thelikelihood that it might be lost. It should also have a “quick release”feature to allow the user to disconnect it from the key ring.Preferably, the RF programmer 12 is less than 1 cubic inch in volume;although larger or smaller volumes may be used. Preferred embodimentsutilize RF frequencies; however, alternative embodiments, may useoptical, infrared (IR), ultrasonic frequencies, magnetic effects, or thelike, to communicate with the external infusion device 10.

[0053] Alternative embodiments of the RF programmer (controller orcommander) 12′, as shown in FIG. 4, may have more complex keypadarrangements 152, and may include a display device 150, such as an LCD,LED, plasma screen, or the like, to assist in programming the externalinfusion device 10. Further alternatives may include a microphone (notshown) and related circuitry to allow voice activated control of theexternal infusion device. In further alternative embodiments, the RFprogrammer 12′ may be formed in larger sizes, comparable to a TVcontroller or a pocket calculator, and may include a display tofacilitate more complicated or easier programming. Still furtherembodiments, may include the ability to receive data and informationfrom the external infusion device 10 and/or a glucose monitoring device,and the ability to relay the information to another medical device,external infusion device 10, glucose monitor device, PC, laptop,Communication-Station, or the like. Data transmission may be to otherdevices or include the capability to receive data or instructions. An RFactivation capability may be included in addition to the programmingcapability.

[0054] Each RF programmer 12 will include the capability to “learn” theunique code of the external infusion device 10 for which it is intendedto be used. In one embodiment, the user will perform the following stepsto learn the unique code: 1) remove the battery from the RF programmer12; 2) wait a few seconds and then replace the battery in the batterycompartment; 3) press and hold the ACT key 110 on the remote keypad 102(preferably, the remote will confirm that it has been activated with along audible beep); and then the remote is held within approximately 12″to 18″ (alternatively larger or smaller distances may be used) of theexternal infusion device 10 to receive the unique code from thetransmitter/receiver 26 of the external infusion device 10. The RFprogrammer 12 will confirm successful learning of the unique code withaudible beeps and/or vibration from the external infusion device 10and/or RF programmer 12. In alternative embodiments, the user maymanually enter or scan in the unique code identifying the RF programmer.In further alternative embodiments, the RF programmer 12 may alsotransmit a unique identification code that uniquely identifies the RFprogrammer 12 to the external infusion device 10 so that the externalinfusion device 10 will only accept commands from a particular RFprogrammer 12. In other embodiments, the unique code includes the serialnumber of the device to prevent confusion with other devices. Inparticular embodiments, the RF programmer 12 transmits commands to theinfusion device 10, but does not include a receiver to receive back datafrom the infusion device 10. In this embodiments the infusion device 10includes the ability to store 3 unique codes to permit the infusiondevice 10 to be programmed by up to 3 different RF programmers 12. Inother embodiments, the infusion device 10 may include more or lessstorage locations to permit programming of the infusion device 10 with acorresponding more or less number of RF programmers 12.

[0055] In preferred embodiments the external infusion device 10 includesa receiver to receive the commands from the RF programmer 12. Normally,the receiver is in a standby mode (e.g., not receiving) and becomesactive for short periods every 2.5 seconds (approximately) to see ifthere is any RF activity from the RF programmer 12. In alternativeembodiments, the receiver of the external infusion device 10 may be oncontinuously or may become active more often or less often, with theselection being dependent on power capacity, expected frequency of useof the RF programmer 12, or the like. Generally, the receiver of theexternal infusion device 10 requires that the RF programmer send anactivating message for a period lasting about 5 seconds for the RFprogrammer to be recognized by the receiver. In alternative embodiments,longer or shorter periods of time for sending the activating message maybe used.

[0056] Once the receiver recognizes that there is a valid RF programmer12 sending a message to the external infusion device 10 (i.e., with thisdevice 10's unique code), the receiver will remain in an active modeuntil a complete sequence of commands has been received, or until thereceiver times out due to a lack of RF communications from the RFprogrammer 12. Preferably, upon recognition of a valid RF programmer 12trying to communicate with the receiver, the external infusion device 10will activate its audio beeper (or its vibrator or the like) to let theuser know that the external infusion device 10 has been activated by theRF programmer 12 Typically, the receiver of the infusion device 10expects to receive a message with a valid preamble and message type, arecognized unique code, a valid function code (e.g., activate, bolus,suspend, or the like), an appropriate message count used by the receiverfor reduction of RF interference problems, and a valid CRC on thetransmitted message to ensure message integrity. Alternativeembodiments, may include different message contents or components.

[0057] In operation, as discussed above, the RF programmer 12 may beused to program several capabilities, such as an audio (or vibration)bolus, a suspension of external infusion device operation, a temporarybasal rate, an extended bolus (such as square wave, ramp, triangular orthe like) or dual wave bolus. In addition, the user may program aprofiled bolus that uniquely matches the needs of the individual user(for instance it may contain square, ramp, pulse or curved portions thatmake up the profile to be delivered over a period of time). It should benoted that the capabilities may also be directly programmed on theexternal infusion device 10 using the same sequence on the keypad of theexternal infusion device 10. The following are examples of how thevarious capabilities can be programmed using the keypad 102 on the RFprogrammer 12 (or similarly with the keypad 24 on the external infusiondevice 10).

EXAMPLE I RF Programmed Audio Bolus

[0058] To deliver an audio bolus with the RF programmer 12, the userwill press the “B” or Up arrow key (▴) 108 in the upper right handcorner of the RF programmer 12 keypad 102. Each time the Up arrow key(▴) 108 is pushed the amount of the audio bolus will increment in either0.5 units or 1.0 units (depending on what the user programmed as theincremental step on the “audio” screen of the Set-up 1 menu—alternativeembodiments may use other increments). In these examples, units are anincrement of insulin. However, alternative embodiments, may define unitsto be any fluid volume, such as micro-liters, ccs, or the like, with thevolume being dependent on the type of fluid to be infused. If the userexceeds the desired setting he can wait for an error signal, such as a“raspberry” type sound, buzzing, vibration, or the like, and then pressthe Up arrow key (▴) 108 on the RF programmer 12 to begin the processagain.

[0059] When the desired audio bolus amount is programmed, the userpresses the “activate” or ACT key 110 in the lower left corner of thekeypad 102 on the RF programmer 12. The external infusion device 10 willthen confirm the audio bolus amount with a series of audible beeps. Inalternative embodiments, vibration may be used instead of or in additionto audible beeps. To deliver the audio bolus, the user will then pressthe ACT key 110 again to start delivery of the bolus. Alternatively, theexternal infusion device 10 may provide an audible indication by speech.In further alternative embodiments, the RF programmer 12′ will have adisplay 150 and will provide a visual confirmation with or without anaudio confirmation.

[0060] Counting the bolus increments will be facilitated by varying theaudio tones for beeps that accompany the Up arrow key (▴) 108 presses.Four notes belonging to a musical chord will be used in repeatingsequence as the Up arrow key (▴) 108 is repeatedly pressed to select adesired bolus amount. In alternative embodiments, more or fewer notes(and/or vibration) may be used. For example, if 0.5U (U-100) is thebolus increment, the first key press of the Up arrow key (▴) 108 willset the external infusion device 10 and LCD 28 to 0.5 U, and it will beaccompanied by the first note in a chord. The second key press of the Uparrow key (▴) 108 will increment the external infusion device and theLCD 28 to 1.0 U, and it will be accompanied by the second note in thechord. The third key press of the Up arrow key (▴) 108 will incrementthe external infusion device 10 and LCD 28 to 1.5 U, and it will beaccompanied by the third note in the chord. The fourth key press of theUp arrow key (▴) 108 will increment the external infusion device 10 andthe LCD 28 to 2.0 U, and it will also be accompanied by the fourth notein the chord. On the fifth key press of the Up arrow key (▴) 108, thedisplayed bolus amount will be incremented again and the audio sequencewill repeat in the same manner as just described.

[0061] When the desired bolus amount is displayed and/or sounded, theuser continues by pressing the ACT key 110. The external infusion device10 will play back the beep sequence generated during the bolus amountselection. The bolus delivery will commence after the user confirms thebolus amount selection by pressing the ACT key 110 once again. To cancelthis bolus before it starts, the user may either allow the externalinfusion device 10 to time out and return to the time display or pressthe Down arrow key (▾) 112. Either of these will be accompanied by a“raspberry” type beep (and/or vibration) indicating the bolus has beencleared. Preferably, a standard time-out delay of 15 seconds applies toall keypresses involved during the bolus amount selection, but othertime periods may be used.

[0062] Preferably, a BOLUS element, the word DELIVERY, and the updatedamount delivered will be displayed on the LCD 28 while delivery is inprogress. The external infusion device 10 will beep once at the end ofthe dose. In alternative embodiments, audible indications may beprovided, such as beeps, chords, speech, or the like, and/or vibration.

EXAMPLE II RF Programmed Suspension of External Infusion DeviceOperation

[0063] To temporarily suspend the operation of the external infusiondevice 10, the user will press the “select” or SEL key 114 in the upperleft hand corner of the keypad 102 of the remote RF programmer 12, andthen press the ACT key 110. The external infusion device 10 will confirmthat it is in suspend mode with three (3) audible beeps (althoughdifferent numbers of beeps and/or vibration may be used). In preferredembodiments, when the external infusion device 10 is in suspend mode,the LCD 28 will show “-S-”, the. word “STOPPED”, and the time that theexternal infusion device 10 was placed in the suspend mode. When in thesuspend mode, there is no drug delivery (either basal rate, or mealboluses). Preferably, the external infusion device 10 will beep an alerttone (and/or vibrate) every half hour to indicate that delivery hasstopped. In alternative embodiments, other time periods may be used, orthe alert tone may be omitted.

[0064] To restart the external infusion device 10, the user will againpress the SEL key 114 and then presses the ACT key 110. The externalinfusion device 10 will beep once (and/or vibrate) to confirm therestart and then resume normal basal delivery and infusion device 10operation. Alternatively, the external infusion device 10 may provide anaudible indication by speech. In further alternative embodiments, the RFprogrammer 12′ will have a display 150 and will provide a visualconfirmation of the status of the external infusion device 10, with orwithout an audio confirmation.

EXAMPLE III RF Programmed Temporary Basal Rate

[0065] A temporary basal rate, or basal override rate, is a rate that isdelivered in lieu of a programmed, user defined profile segment ratethat is generally delivered during this time period. The temporary basalrate is programmed with a rate and a duration.

[0066] To set a temporary basal rate, the user will press the “T” orDown arrow key (▾) 112 in the lower right hand corner of the keypad 102on the RF programmer 12. Each press of the Down arrow key (▾) 112 willincrement the duration of the temporary basal rate by 30 minutes.Counting the temporary basal rate duration increments will befacilitated by varying the audio tones for beeps that accompany the Downarrow key (▾) 112 presses. Four notes belonging to a musical chord willbe used in repeating sequence as Down arrow key (▾) 112 is repeatedlypressed to select a desired duration of the basal rate. In alternativeembodiments, more or fewer notes (and/or vibration) may be used. Thetemporary basal duration may be programmed from 30 minutes to 24 hoursin half-hour increments. In alternative embodiments, other time periodsmay be used. In preferred embodiments, the tone of the beeps for atemporary basal rate may be distinctly different from a tone forincrementing a bolus. In alternative embodiments, different vibrationmay be used instead or in addition to the different audible beeps. Ifthe user exceeds the desired setting, they can wait for an error signal,such as a “raspberry”, buzzing, vibration, or the like, and then pressthe Down arrow (▾) 112 to begin the process again.

[0067] When the desired temporary basal rate duration has been set, theuser will press the ACT key 110. The external infusion device 10 willconfirm the duration of the temporary bolus rate with a series ofaudible beeps (and/or vibration). The user will then press the ACT key110 again to confirm and accept the duration of the temporary basalrate. If the ACT key 110 is not pushed to confirm the amount, theexternal infusion device 10 will emit an audible error signal such as a“raspberry”, buzzing, vibration, or the like. Alternatively, theexternal infusion device 10 may provide an audible indication by speech.In further alternative embodiments, the RF programmer 12′ will have adisplay 150 and will provide visual confirmation of the temporary basalrate duration, with or without an audio confirmation.

[0068] To set the amount of the temporary basal rate, the user willpress the Down arrow key (▾) 112 again. Each press of the Down arrow key(▾) 112 will increment the amount of the temporary basal by 0.1 units.Counting the amount temporary basal rate increments will be facilitatedby varying the audio tones for beeps that accompany the Down arrow key(▾) 112 presses. Four notes belonging to a musical chord will be used inrepeating sequence as Down arrow key (▾) 112 is repeatedly pressed toselect a desired amount of the temporary basal rate. In alternativeembodiments, more or fewer notes (and/or vibration) may be used. Inthese examples, units are an increment of insulin. However, alternativeembodiments may define units to be any fluid volume, such asmicroliters, ccs, or the like, with the volume being dependent on thetype of fluid to be infused. The rate may be set to a value from 0.0 Uto the maximum programmable value of the basal rate. In alternativeembodiments, different increments may be used. Preferably, the tone ofthese beeps (and/or vibration) will be distinctly different than thetone (and/or vibration) for setting the duration of the temporary basalrate. Once the desired amount has been set, the user will press the ACTkey 110. The external infusion device 10 will confirm the amount of thetemporary basal rate with a series of audible beeps (and/or vibration).The user will then press the ACT key 110 again to confine and accept theamount of the temporary basal rate. If the ACT key 110 is not pushed toconfirm the amount, the external infusion device 10 will emit an audibleerror signal, such as “raspberry”, buzzing, vibration, or the like.Three short beeps (an/or vibration) every 30 minutes will confirm thatthe temporary basal rate is active. Alternatively, the external infusiondevice 10 may provide an audible indication by speech. In furtheralternative embodiments, the RF programmer 12′ will have a display 150and will provide visual confirmation of the temporary basal rate, withor without an audio confirmation.

[0069] To cancel a programmed temporary basal rate at any time duringits intended operation, and resume the normal programmed basal rate, theuser presses the Down arrow key (▾) 112 and then presses the SEL key 114on the keypad 102 of the RF programmer 12. If a temporary basal rate hadtime remaining, the user will hear a long beep (and/or vibrate) toconfirm that the temporary basal has been canceled. Otherwise, if notime was remaining, the user hears an error signal such as a“raspberry”, buzzing, vibration, or the like, indicating that there wasno time remaining on the temporary basal rate. Alternatively, theexternal infusion device 10 may provide an audible indication by speech.In further alliterative embodiments. the RF programmer 12′ will have adisplay 150 and will provide visual confirmation of the temporary basalrate, with or without an audio confirmation.

EXAMPLE IV RF Programmed Extended Bolus

[0070] An extended bolus (such as a square wave bolus, ramp bolus,triangular bolus, profiled bolus or the like) is a bolus that isdelivered over an extended period of time; rather, than all beingdelivered at once. To program an extended bolus with the RF programmer12, the user will need access to the display LCD 28 of the externalinfusion device or perform the programming in two separate steps.Alternatively, an RF programmer 12′ having a built in display 150 may beused.

[0071] To set an extended bolus, the user will set the duration of theextended bolus in the same manner that they set the duration for aTemporary Basal Rate. This involves using the Down arrow key (▾) 112 inthe lower right corner of the keypad of the RF programmer 12, in thesame mailer as described above. The user will also select the type ofextended bolus such as a square wave bolus, ramp bolus, triangularbolus, profiled bolus, or the like, to be delivered by previousselection of the type of extended bolus in the setup mode or by using anRF programmer in conjunction with a display. The remainder of theexample demonstrates setting a square wave bolus.

[0072] When the ACT key 110 is pressed while a desired bolus amount isdisplayed, the bolus duration will be displayed on the LCD 28. Thedefault bolus duration can be 30, 60 or 90 minutes, depending on thelargest basal value of current setting and the desired bolus amount. Theduration may be scrolled by using the Up arrow key (▴) 108 and the Downarrow key (▾) 112 on the keypad 102 of the RF programmer 12. Pressingthe Up arrow key (▴) 108 will cause the duration to scroll in incrementsof 30 minutes up to 8 hours (the preferred maximum duration—althoughother durations or increments may be used), at which point it will wraparound to minimum duration. Pressing the Down arrow key (▾) 112 willcause the duration to wrap around to 8 hours, then scroll down inincrements of 30 minutes. In further embodiments, the use of the Downarrow (▾) 112 will always stop at zero to avoid a wrap-around or requireone or more additional depressions (possibly accompanied by a beepand/or vibration) to warn a user that they are now at the maximum value.Alternatively, the RF programmer 12′ may include different additionalkeys (such as 152 in FIG. 4) that can be used to implement the squarewave bolus, or a selectable menu on the RF programmer 12′.

[0073] Next, to set the amount of the square wave bolus, the user willpress the Up arrow key (▴) 108 in the upper right hand corner of thekeypad 102 of the RF programmer 12. Each depression will enableincrementing the amount of the square wave bolus in 0.1 unit increments,although other increments may be used. The external infusion device 10will give a distinct auditory (and/or vibrating) confirmation of theselected bolus amount. The square wave will not be implemented until theuser presses the ACT key 110 to accept the selected amount. Preferably,the external infusion device 10 provides confirmation by an audible beep(and/or vibration). Alternatively, the external infusion device 10 mayprovide an audible indication by speech. In further alternativeembodiments, the RF programmer 12′ will have a display 152 and willprovide visual confirmation of the square wave bolus, with or without anaudio confirmation.

[0074] To enhance flexibility, preferred embodiments of the externalinfusion device 10 will enable the user to deliver a normal bolus duringa programmed Square Wave. Once the normal bolus has been delivered, thesquare wave will resume operation until completed.

EXAMPLE V RF Programmed Dual Wave Bolus

[0075] A dual wave bolus is a combination of a normal (or immediatelygiven) bolus with a square wave bolus. To program a dual wave bolus withthe RF programmer 12, the user will need access to the display LCD 28 ofthe external infusion device or perform the programming in two separatesteps Alternatively all RF programmer 12′ having a built in display 150may be used.

[0076] To set a dual wave bolus, the user will press the ACT key 110 onthe bolus history screen. The word “NORMAL” will start to blink on theLCD 28 and/or provide an audible (and/or vibration) indication. The usercall press the Up arrow key (▴) 108 or Down arrow key (▾) 112 to choosethe type of bolus desired. By pressing the ACT key 110, while the LCD 28of the external infusion device 10 blinks the word “DUAL” (and/orprovides an audible indication), a dual bolus is chosen. The LCD 28 ofthe external infusion device 10 will show the word “NOW” and/or thedashes for the normal bolus portion amount will blink on the LCD 28(and/or an audible and/or vibration indication is provided). The usercan then select a bolus amount for the “normal” bolus portion using theUp arrow key (▴) 108 or Down arrow key (▾) 112, and then press the ACTkey 110. The LCD 28 of the external infusion device 10 will show theword “SQUARE” and/or the dashes for the bolus amount will now blink(and/or an audible and/or vibration indication is provided). The usercan press the Up arrow key (▴) 108 or the Down arrow key (▾) 112 tochoose the desired square wave bolus portion amount. When the ACT key110 is pressed, while a desired square wave bolus portion amount isdisplayed on the LCD 28, the square wave bolus portion duration will bethen displayed (and/or an audible and/or vibration indication isprovided). The user can then select the desired square wave bolusportion duration from 30 minutes to 8 hours (although other incrementsor duration's may be used). After the ACT key 110 is pressed for thedesired square wave bolus portion duration. the external infusion device10 will start delivering the normal bolus portion first. The square wavebolus portion will then start right after the end of the normal bolusportion. The word “BOLUS” and the amount of the bolus that has beendelivered so far will be displayed on the LCD 28 (and/or an audibleand/or vibration indication will be provided). When the dual bolus isfinished, the external infusion device 10 will beep (and/or vibrate)an(d display the amount of the bolus delivered for 5 seconds, thenreturn to the normal time display. Alternatively, the external infusiondevice 10 may provide an audible indication by speech. In furtheralternative embodiments, the RF programmer 12′ will have a display 150and will provide visual confirmation of the square wave bolus, with orwithout an audio confirmation.

[0077] Other programming, commands, or data transfer may be accomplishedby the RF programmer 12 (or remote commander), and the RF programmer 12(Or remote commander) should not be limited to the above-describedExamples I-V. For instance, the RF programmer 12′, since it includes adisplay 150 may use the same programming protocol and key sequences asthose used to program the external infusion device 10 using the keypad24 and LCD 28 on the external infusion device 10. Alternatively, the RFprogrammer 12′ may use more sophisticated programming techniques, suchas single key programming, if the display 150 includes the capability touse touch screen techniques, or may use additional keys in the keypad152 that are specifically identified with particular programmingfeatures on the external infusion device 10.

[0078] Bolus Estimator

[0079] The Bolus estimator 14 (or carbohydrate estimator that estimatesa bolus based on carbohydrate consumption (CHO)) assists the user withcarbohydrate counting and in determining precise dosing adjustments toaccount for meals. Carbohydrates are the primary, but not the only,factor affecting blood glucose levels. Generally, it is sufficient toaccount just for the carbohydrates. It also encourages the user to entercurrent blood glucose values before using this feature, which will alsobe viewed quite favorably by the health care professional, since itincreases compliance with the medical regimen and improves control. Inalternative embodiments, the bolus estimator 14 in the external infusiondevice 10 can be connected or coupled to a glucose monitor by way of theRF programmer 12 (or other data transfer) to provide direct input to thebolus estimator 14.

[0080] In preferred embodiments, as, shown in FIGS. 1, 6, 7 and 8(b),the bolus estimator 14 is used to assist the external infusion device 10user with the estimations that are done to determine the proper bolusamount that is needed to cover the anticipated carbohydrate intake atmeals. The bolus estimator 14 does this by suggesting a bolus based on apre-programmed carbohydrate ratio that is stored in the memory 22 of theexternal infusion device 10. The bolus estimator 14 will also take intoaccount the user's insulin sensitivity and the differential between theuser's pre-programmed target blood glucose (BG) level and the user'scurrent BG level at the time the carbohydrate estimator 14 is activated.The recommendation, or result of the bolus estimator 14, is sometimesreferred to as a “correction bolus”.

[0081] The bolus estimator 14 is generally activated by the user, orpreferably the health care professional, in the Set-up II menu of theexternal infusion device 10 (see FIGS. 6 and 8(b)), before it isoperational, and preferably after the user has demonstrated a sufficientunderstanding of estimating carbohydrate intake. In preferredembodiments, the bolus estimator 14 is activated and programmed by usingthe keypad 24 on the external infusion device 10. However, inalternative embodiments, the bolus estimator 14 may be programmed andactivated with an RF programmer 12 or 12′. In further alternativeembodiments, the current glucose readings for the user my be provided byreceipt of the glucose level measurement from a glucose monitor or viathe RF programmer 12 to facilitate a correction for changing bloodglucose (BG) levels. Further description of correcting infusion ratesbased on blood glucose readings may be found in U.S. Pat. No. 5,569,186to Lord et al., entitled “CLOSED LOOP INFUSION PUMP SYSTEM WITHREMOVABLE GLUCOSE SENSOR,” and U.S. Pat. No. 5,665,065 to Colman et al.,entitled “MEDICATION INFUSION DEVICE WITH BLOOD GLUCOSE DATA INPUT”,which are herein incorporated by reference. In alternative embodiments,the user may be able to rise other combinations of the values to suggestdifferent bolus types and amounts. In alternative embodiments, thecarbohydrate estimator 14 can be used in a closed-loop system to augmentthe readings or check the closed-loop system's capability based oncarbohydrate estimated meals. In still further embodiments, the bolusestimator 14 may be used to calculate correction boluses based on otherparameters, with the type of bolus corrections being determined by thefluid being infused, body characteristics, or the like. Preferably, thebolus estimator 14 uses stored values or parameters related to theindividual with current values, parameters or measurements and analgorithm to provide a recommended bolus that can be accepted, modifiedor rejected by the user. For instance in pregnancy, tocolysis may beinfused and the measurement of the contraction rate may be used tosuggest additional boluses of tocolysis medication., In HIV cases, abolus amount of medication being infused may be adjusted based on arelationship to the current viral loads in the patient. In stroke orcardiac cases, the coagulation rate may be used to determine the bolusamount of heparin to be administered. Other calculations may be made andshould not be limited to the above-described examples.

[0082] After the bolus estimator 14 has been enabled, the user will beprompted to store the following three (3) values in the memory 22 of theexternal infusion device 10. In alternative embodiments, more or fewervalues may be needed or used. These values are used by the bolusestimator 14 and the processor 18 of the external infusion device 10 toperform the necessary calculations in suggesting a bolus amount. Inpreferred embodiments, access to programming and changing these valuesmay be restricted to the health care professional. In alternativeembodiments, these values can be restricted to entry through an RFprogrammer 12 or a connection of the external infusion device 10 with aprogramming device, such as a PC, laptop or the like. The inputtedvalues needed to be stored for the bolus estimator 14 are:

[0083] Target Blood Glucose (Target), which is the target blood glucose(BG) that the user would like to achieve and maintain. Generally, theprogrammable blood glucose (BG) values for this range are between 60 to200 in five unit increments. Preferably, the carbohydrate calculator hasthe capability to accept values that range between 20 to 600 in 1 unitincrements to cover a large number of possible scenarios. However, inalternative embodiments, different ranges and increments may be used.

[0084] Insulin Sensitivity (Set Sens), which is a value that reflectshow far the user's blood glucose drops in milligrams per deciliter(mg/dl) when one unit of insulin is taken. Preferably, the programmablevalues for this range are between 5 to 180 in one unit increments.However, in alternative embodiments, different ranges and increments maybe used. In preferred embodiments, insulin sensitivity is programmablefor up to four different time periods, the use of which will requirefour separate profiles to be stored in the memory 22. Setting theInsulin Sensitivity profiles is similar to setting the basal profiles.In alternative embodiments, more or fewer time periods (andcorresponding profiles) may be used.

[0085] Carbohydrate Ratio (Set Carbs), which is a value that reflectsthe amount of carbohydrates that are covered by one unit of insulin.Generally, the values are in the range of 1 to 300 in increments of 1unit (or, alternatively, in ranges of 0.1 to 5.0 in increments of 0.1for carbohydrate exchanges). Preferably, the programmable values forthis range are between 5 to 30 in one unit increments. However, inalternative embodiments, different ranges and increments may be used.

[0086] As a safety precaution, the user or healthcare professional mayalso set a Lockout Period, which takes into account the pharmacokineticeffect of insulin when suggesting a bolus. The purpose is to prevent asuccessive use of a correction bolus when the pharmacokinetic effects ofthe previous bolus have not yet been accounted for. The programmablevalues for this range are between 30 minutes to 240 minutes,programmable in 15 or 30 minute increments. However, in alternativeembodiments, different ranges and increments may be used. In furtheralternative embodiments, the lock out period may be automaticallycalculated based on boluses recently delivered and/or canceled based onnew blood glucose (BG) readings. In other embodiments, the carbohydratecalculator 14 may include a programmable reminder to check thepost-prandial blood glucose value to determine if additional boluses andor corrections should be made at a later time after the meal. Theprogrammable reminder values are between 30 minutes to 240 minutes,programmable in 15 or 30 minute increments. However, in alternativeembodiments, different values and increments may be used.

[0087] After the above values are set in the memory 22 of the externalinfusion device 10, the bolus estimator 14 will suggest a bolus based onthe entry of the estimated carbohydrate intake and current and targetblood glucose (BG) levels. The calculation will only be performed if thethree values are programmed and stored in the memory 22. Preferredembodiments use the following equation:${Bolus} = {\frac{( {{{Current}\quad {BG}} - {{Target}{BG}}} )}{{Insuline}\quad {Sensitivity}} + \frac{CarbohydratesToBeConsumed}{CarbohydrateRatio}}$

[0088] If the user wishes the external infusion device 10 to suggest abolus for the estimated carbohydrate intake only, then the only valuethey need to program is for the Carbohydrate Ratio, and the BG portionof the equation will be ignored. In alternative embodiments, variationsor different equations may be used.

[0089] In operation, once the bolus estimator 14 has been enabled andthe above listed values have been programmed into the memory 22 of theexternal infusion device 10, the bolus estimator 14 can be used tosuggest a correction or meal bolus. The user may then accept or changethe bolus amount suggested by the bolus estimator 14. In one embodiment,processor 18 stores in memory 22 a record of whether the suggested bolusamount from the bolus estimator 14 was accepted or changed by the user,and records the suggested and changed bolus amounts. The stored data canbe used for later analysis by downloading the data to a computer by RFor IR transmissions, for example by IR transmissions from the externalinfusion device 10 through the communication station 8 to the computer6, as shown in FIG. 15, or the like. The following examples illustratehypothetical carbohydrate calculation scenarios. The examples show useof the bolus estimator 14 by the keypad 24 on the external infusiondevice 10. However, it should be understood that the bolus estimator 14could be activated and programmed by the RF programmer 12 or the like.Alternatively, the keypad 24 (or RF programmer 12) may include anadditional key.

[0090] Preferred embodiments use a normal bolus, In alternativeembodiments, the user may be given the choice of a normal, dual, squarewave bolus, extended bolus, profiled bolus, or the like, by enablingthese capabilities on the variable bolus menu in the Setup II menu (seeFIGS. 6 and 8) on the external infusion device 10. If the variable boluscapability is not enabled, then every bolus would be a normal bolus. Asdiscussed, preferred embodiments of the present invention use normal onetime boluses. However, alternative embodiments may utilize differentbolus types to spread out the correction or meal bolus determined by thecarbohydrate estimator 14.

[0091] The same set of pre-programmed values as described above andshown below in Table 1 will be used for each of the following examplesVI-IX: TABLE 1 Pre-programmed Values for the Examples Pre-programmedValues Target BG: 100 Insulin Sensitivity: 30 Carbohydrate Ratio: 15Lockout Period: 60

EXAMPLE VI Bolus Estimator—Square Wave

[0092] The user presses the SEL key 114 and then the ACT key 110 on theexternal infusion device 10 to choose a “Normal” bolus, and uses the ACTkey 110 to select the carbohydrate estimator 14. To operate the bolusestimator 14, and assuming that the user measures his/her blood sugarlevel to be 160 mg/dl, and assuming the user estimates that a meal of 75grams of carbohydrates is to be consumed, the following “dialog” occursbetween the user and the external infusion device 10:

[0093] External infusion device 10 Prompt: “Enter BG” (preferably, therewill be three dashes in the upper right corner of the display—althoughother displays or indications may be used).

[0094] User: Enters the value “160” by scrolling the Up arrow key 10 andpressing the ACT key 110. 160 is displayed and then entered.

[0095] External infusion device 10 Prompt: “# gm CHO” meaning the numberof grams of carbohydrate to be consumed (there will be three dashes inthe upper right corner of the display—although other displays orindications may be used).

[0096] User: Enters the value “75” by scrolling the Up arrow key (▴) 108and pressing the ACT key 110. 75 is displayed and then entered.

[0097] External infusion device 10 Prompt: Suggests a “7.0” unit bolus(2 units of correction and 5 units to account for the carbohydrates tobe consumed)

[0098] User: Can accept the suggested bolus by pushing the ACT key 110or use the Up arrow key (▴) 108 or the Down arrow key (▾) 112 to selecta different bolus amount, and then presses the ACT key 110 to start thebolus.

EXAMPLE VII Bolus Estimator—Dual Wave

[0099] The user presses the SEL key 114 and chooses a “Dual” wave bolus,and then the ACT key 110. To operate the bolus estimator 14, andassuming that the user measures his/her blood sugar level to be 160mg/dl, and assuming the user estimates that a meal of 75 grams ofcarbohydrates is to be consumed, the following “dialog” occurs betweenthe user and the external infusion device 10. The following “dialog”will then take place between the user and the external infusion device10:

[0100] External infusion device 10 Prompt: “Enter BG” (there will bethree dashes in the upper right corner of the display—although otherdisplays or indications may be used).

[0101] User: Enters the value “160” by scrolling the Up arrow key (▴)108 and pressing the ACT key 110. 160 is displayed and then entered.

[0102] External infusion device 10 Prompt: “# gm Carbs” which means thenumber of grams of carbohydrate to be consumed (there will be three(lashes in the upper right corner of the display—although other displaysor indications may be used).

[0103] User: Enters the value “75” by scrolling the Up arrow key (▴) 108and presses the ACT key 110. 75 is displayed and then entered.

[0104] External infusion device 10 Prompt: Suggests a “7.0” unit bolus.

[0105] User: Can accept the suggested bolus by pressing the ACT key 110or use the Up arrow key (▴) 108 or the Down arrow key (▾) 112 to selecta different bolus amount.

[0106] External infusion device 10 Prompt: “Now” with the accepted valueof “7.0” units blinking. Typically the user will scroll down using theDown arrow key (▾) 112 to select only part of the bolus now. Lets saythe user selects “2.0” and presses the ACT Key 10.

[0107] External infusion device 10 Prompt: “Square” will appear on thescreen with the remainder of the bolus (i.e., “5.0”) blinking. The usercan again select this amount or scroll to a different amount. Theduration will be set by activating the SEL key 114 and incrementing thetime.

EXAMPLE VII Bolus Estimator—Square Wave—Lower BG

[0108] The user presses the SEL key 114 and then the ACT key 110 on theexternal infusion device 10 to choose a “Normal” bolus, and uses the ACTkey 110 to select the bolus estimator 14. To operate the bolus estimator14, and assuming that the user measures his/her blood sugar level to be70 mg/dl, and assuming the user estimates that a meal of 75 grams ofcarbohydrates is to be consumed the following “dialog” occurs betweenthe user and the external infusion device 10:

[0109] External infusion device 10 Prompt: “Enter BG” (there will bethree dashes in the upper right corner of the display—although otherdisplays or indications may be used).

[0110] User: Enters the value “70” by scrolling the Up arrow key (▴) 108and pressing the ACT key 110. 70 is displayed and then entered.

[0111] External infusion device 10 Prompt: “# gm Carbs” which means thenumber of grams of carbohydrate to be consumed (there will be threedashes in the upper right corner of the display—although other displaysor indications may be used).

[0112] User: Enters the value “75” by scrolling the Up arrow key (▴) 108and presses the ACT key 110. 75 is displayed and then entered.

[0113] External infusion device 10 Prompt: Suggests a “4.0” unit bolus(−1 unit correction and 5 units to account for the carbohydrates to beconsumed).

[0114] User: Can accept the suggested bolus by pressing the ACT key 110or use the Up arrow key (▴) 108 or the Down arrow key (▾) 112 to selecta different bolus amount.

[0115] Preferred embodiments of the bolus estimator 14 utilize generalrules to minimize the potential for inaccurate results from the bolusestimator 14 or administering a bolus at an inappropriate time. Forinstance, if a correction bolus has been previously given such that theBG Now>BG Target, then the Lockout period is activated and the bolusestimator 14 will not calculate a correction bolus. In alternativeembodiments, the bolus estimator 14 may determine a bolus based oncarbohydrates to be consumed and omit the portion of the calculationthat utilizes the blood glucose level to determine the correctionportion of the bolus. Thus, the external infusion device 10 will notprompt the user with “Enter BG” during the Lockout period, and willeffectively operate only as a carbohydrate estimator. Once the Lockoutperiod has expired, the external infusion device 10 will prompt the userfor a current BG value, and then suggest a correction bolus if the userenters a current BG value. Also, if the bolus estimator 14 estimates abolus to be a negative value (BG is below target and carbohydrate intakeamount is minimal) then the external infusion device 10 will display “NoBolus!” as a warning. Also, if the user enters a current blood glucose(BG) level that is lower than a certain value, such as 50 (althoughother values may be used), the external infusion device will display“Low BG”.

EXAMPLE IX Bolus Estimator—Insulin Duration Factor

[0116] A further embodiment of the bolus estimator 14 may include theability to account for the effects of recently taken insulin that isstill, at least partially, still active in the body of the user. Theconcern would be that the remaining insulin could have the effect oflowering the blood glucose level too quickly, or too far, if theremaining insulin was not accounted for. Thus, this embodiment utilizesan Insulin Duration Factor to account for the effects of the insulinstill remaining in the body.

[0117] The Insulin Duration Factor would also be a programmableparameter that is in the Setup II section of the pump along with theother parameters, as described above. The user would program theapproximate duration time that insulin is active in their system. Forinstance, users of fast acting insulin analogs would program 1 to 4hours in 15 or 30 minute intervals, and users of Regular insulin wouldprogram 2 to 8 hours in 15 or 30 minute intervals. However, inalternative embodiments, different values and increments may be used.Preferably, the insulin duration factor should be selected and adjustedby the health care professional or the user upon recommendation and/orconsultation with the health care professional. Preferred embodimentsuse the following equation (note if a negative value is returned (i.e.,the insulin from a previous bolus is used up) the equation will return avalue of 0 for no insulin remaining to avoid over correcting):${{Insulin}\quad {Remaining}} = {{\frac{( {{InsulineDurantionFactor} - {{TimeSince}\quad {LastBolus}}} )}{InsulinDurationFactor}{If}} \geq 0}$

[0118] Otherwise

[0119] Insulin Remaining=0

[0120] In this example, it is assumed that the user programs a 3 unitcorrection bolus at 11:00 am to correct for a 190 BG value. The userthen decides to use the bolus estimator 14 at 12 Noon to estimate abolus for meal containing 75 grams of carbohydrate. The Insulin DurationFactor is set to 3 hours.

[0121] The user presses the SEL key 114 and then the ACT key 110 on theexternal infusion device 10 to choose a “Normal” bolus, and uses the ACTkey 110 to select the bolus estimator 14. To operate the bolus estimator14, and assuming that the user measures his/her blood sugar level to be160 mg/dl, and assuming the user estimates that a meal of 75 grams ofcarbohydrates is to be consumed, the following “dialog” occurs betweenthe user and the external infusion device 10:

[0122] External infusion device 10 Prompt: “Enter BG” (preferably, therewill be three dashes in the upper right corner of the display—althoughother displays or indications may be used).

[0123] User: Enters the value “160” by scrolling the Up arrow key 10 andpressing the ACT key 110. 160 is displayed and then entered.

[0124] External infusion device 10 Prompt: “# gm CHO” meaning the numberof grams of carbohydrate to be consumed (there will be three dashes inthe upper right corner of the display—although other displays orindications may be used).

[0125] User: Enters the value “75” by scrolling the Up arrow key (▴) 108and pressing the ACT key 110. 75 is displayed and then entered.

[0126] Insulin Remaining: 3.0 (Insulin Taken)×⅔ (Insulin DurationRemaining) (2.0) units

[0127] External infusion device 10 Prompt: Suggests a “5.0” Unit bolus(2 units of correction and 5 units to account for the carbohydrates tobe consumed and a subtraction to account for the remaining insulin inthe user).

[0128] User: Can accept the suggested bolus by pushing the ACT key 110or use the Up arrow key (▴) 108 or the Down arrow key (▾) 112 to selecta different bolus amount, and then presses the ACT key 110 to start thebolus.

[0129] Since the external infusion device 10 stores the time of eachbolus delivery, the above simple algorithm can be designed to take intoaccount the amount of insulin that might still be remaining in theuser's body from a previous bolus. The longer the programmed time forthe “Insulin Duration Factor” then the more conservative the estimatebecomes. In further embodiments, the external infusion device 10 couldadjust for several boluses that were delivered within the insulinduration window. Although it is difficult to predict how long insulinwill actually remain active in the body, the above described algorithmdoes at least consider the effects on the amount of insulin actuallyneeded. This provides an additional level of conservative estimation inthe external infusion device 10 by accounting for insulin deliveredwithin a programmable window. Without such an algorithm, in the exampleabove the pump would have suggested a “7.0” unit bolus because theremaining insulin would not have been accounted for in the suggestedbolus.

[0130] The bolus estimator 14 has the advantage of prompting the user toenter his/her blood glucose (BG) value, and thus serves as a usefulreminder to check BG levels regularly. This makes testing moreadvantageous then ever, since the results directly assist the user inmaintaining control of his/her condition. Also, the bolus estimator 14enables the external infusion device 10 to capture information oncarbohydrate intake which is valuable for helping the user to refinecarbohydrate counting skills. This data may also be downloaded to a PC,laptop, Communication-Station, RF programmer, or the like.

[0131] In further embodiments, an external infusion device 10 and usercan utilize the bolus estimator 14 information to “learn” insulinsensitivity values, carbohydrate counting, the effects of high fat mealsand other variables that can lead to better control, and use this toadjust the results of the bolus estimator 14. In alternativeembodiments, the user can omit entering specific carbohydrate amountseach time calculations are made by the user. For instance, the externalinfusion device 10 may store the carbohydrate amounts for several mealsthat are regularly eaten by the user in the memory 22, and then allowthe user to recall the stored meals. In other alternative embodiments, alist of general foods may be provided with a carbohydrate equivalent. Instill further embodiments, the external infusion device 10 may utilize amore complicated keypad and/or RF programmer 12, and a code is assignedfor each food. Then the code for each food to be consumed is enteredinto the external infusion device 10.

[0132] Vibration Alarm

[0133] Further embodiments of the present invention include a vibrationalarm 16 that provides a noticeable vibration in addition to or in lieuof an audible alarm. The resulting tactile sensation of the vibrationmake the alarms more noticeable during sleep, when not thinking clearlydue to various conditions, or the like, to improve the likelihood thatthe user will respond to an alarm. Thus, a vibration alarm 16 canimprove safety and control. In addition, the vibration alarm 16 may beless publicly noticeable, and thus more useable in quiet settings, suchas libraries, lectures, shows, or the like, or in loud settings wherethe alarm might go unnoticed, such as parties, concerts, or the like. Infurther embodiments, the RF programmer 12 may include a vibration alarm(not shown) that can deliver a vibration alarm to the user in additionto, or instead of, the vibration alarm 16 from the external infusiondevice 10. Alternatively, the RF programmer 12 may provide a vibrationalarm and the external infusion device 10 may provide an audible alarmor vice versa.

[0134] The vibration alarm 16 also provides an additional capabilityused during priming or operation of the external infusion device 10. Ithas been found that activating the vibration alarm 16. before or duringpriming, will assist in removing air bubbles in the reservoir or tubing.This procedure minimizes the amount of medication that must be expelledto clear the air bubbles, by allowing bubbles to move towards the outletand the tubing based on the agitation of the reservoir. Use of thevibration alarm 16 during priming can result in substantial savings whenusing expensive or concentrated medications with the external infusiondevice 10. This also simplifies and somewhat automates the priming ofthe external infusion device 10. In addition, the vibration alarm 16 maybe used to agitate the medication (such as suspensions of a drug) duringadministration so as to minimize sedimentation or separation of themedication, or, if power requirements are an issue, between infusionincrements of the fluid by the external infusion device 10, if suchagitation is desired.

[0135] Other Capabilities

[0136] Particular embodiments will include a “Low Reservoir Alert”. Thealert will sound when the plunger of the external infusion device 10reaches the point where approximately 0.200 ml of fluid remains in thereservoir. However, in alternative embodiments, larger or smalleractivation thresholds may be used. An icon indicating “Low Volume” willappear on the main LCD 28 screen until the condition is corrected. Ifcorrection of the low volume has not happened at an approximate level of0.100 ml, the external infusion device 10 will beep again. However, inalternative embodiments, larger or smaller activation thresholds may beused. Preferably, the external infusion device 10 will keep track of thereservoir volume in the software and request the user to update thereservoir volume manually whenever the prime function is activated.

[0137] Other embodiments may utilize a “Take a Break Bolus”. This isparticularly well adapted for short acting medications or fluids. Thepurpose of this capability is to deliver an extra bolus beforedisconnecting from the external infusion device 10, to make certain thatthe clinically needed amount of medication or fluid is delivered beforeinterrupting the administration. This will help the user remain abovethe minimum therapeutic level during an interruption of medication orfluid delivery. Preferably, four durations of an interruption of themedication or fluid infusion will be possible: 30 minutes; 1 hour; 1hour and 30 minutes; and 2 hours. However, additional, or longer orshorter intervals may be used. Generally, this capability is activatedin the Setup II menu by the health care specialist, who will program thedose for each of the 4 possible times of delivery interruptions. Thedose is set based on the medication or fluid and the condition of theuser. If the health care specialist programs only certain durations (forexample 30 minutes and 1 hour only), the user will only be able to takea break for those durations. In preferred embodiments, in the “Take aBreak Bolus” screen, the user will program the duration of the plannedinterruption. The external infusion device 10 will then beep after thedelivery of the previously set dose. The user will then disconnect fromthe external infusion device 10 and will be reminded by the externalinfusion device 10 to reconnect when the time is up. Preferably, thereminder alarm will continue to sound (or vibrate) until the userreactivates the external infusion device 10.

[0138] Particular embodiments include a “Lockout function” Preferredembodiments will have multiple lockout levels, with the selection bedependent on the anticipated usage, the external infusion device model,the sophistication of the user, or the like. For instance, the followinglockout levels may be used (a lockout levels means that some of thefeatures of the external infusion device will not be accessible to thepatient (or user), but will be accessible to the Health CareProfessional or the parent of a child using the external infusion device10):

[0139] “None” (0) will let the user program and access all features ofthe external infusion device 10;

[0140] “Setup” (1) will lock the user out of changing both Setup I andSetup II parameters. The user will only have access to activatedfeatures of the external infusion device 10, but can not change thepre-set parameters. The user will be able to review the settings, andonly change the lockout level with an authorized key sequence. The onlySetup feature that will still be available is Selftest.

[0141] “All except Suspend” (2) will only allow the user to suspend theexternal infusion device and to perform a Selftest. All other featureswill be locked out. The user will be able to review the settings, andonly change the lockout level with an authorized key sequence.

[0142] The “Lockout function” will be in Setup II. A special keysequence (or code) will be required to change the lockout level. Thiswill minimize the possibility of an unauthorized change of the lockoutlevels. In preferred embodiments, an icon (lock) will be displayed onthe LCD 28 when the external infusion device 10 is in Lockout mode 1 orin Lockout mode 2.

[0143] Preferred embodiments of the external infusion device 10 willinclude a configurable menu that is accessible by password through theuse of a PC, laptop, RF programmer or the like. This ability allows thephysician, or sophisticated user, to select only the external infusiondevice 10 capabilities that are required for an individual user. A “lockout” capability will enable the physician to exclude certain optionsfrom the user. This may be useful with new users or children using theexternal infusion device 10.

[0144] Further embodiments may include a “Suspend/Storage Mode”. Inaddition to the regular Suspend Mode (discussed above), the externalinfusion device 10 can be put in a “Storage Mode” in which no recurringalert (beeping and/or vibrating) will remind the user of the externalinfusion device 10 being in the “Storage Mode”. Thus, for example, in“Suspend Mode”, the external infusion device 10 will display the time ofday, STOPPED and -S- on the LCD 28. In addition, the external infusiondevice 10 will beep (and/or vibrate) 6 times every 30 minutes as areminder. In suspend “Storage Mode”, the external infusion device 10 LCD28 will display the -S- only and will not repeatedly beep (and/orvibrate).

[0145] In preferred embodiments, software options will appear as choicesfor the user if they are first selected from the Main Menu, the Setup Iand Setup II screen, as shown in FIGS. 6-12. The physician will also beable to control what range of choices are available for the user, eitherin the office or remotely through a PC connected to aCommunication-Station. In preferred embodiments, the external infusiondevice 10 will have the ability to transmit all the stored memorycontent to a Computer 6 or external FAX/Modem connected to aCommunication-Station 8, as shown in FIG. 15. Further description of aCommunication Station of this general type is be found in U.S. Pat. No.5,376,070 to Purvis et al., entitled DATA TRANSFER SYSTEM FOR ANINFUSION PUMP, which is herein incorporated by reference.

[0146] Preferred embodiments, use scrollable menus to set variouscapabilities. In alternative embodiments, different menu structures orways of moving through the menus may be used. In preferred embodiments,the user presses the SEL key 114 to scroll the external infusion device10 through a series of informative displays or Select States (e.g., mainmenu, setup I and setup II—see FIGS. 6-12). The displays differdepending upon the current status (state of software execution) of theexternal infusion device 10.

[0147] Preferably, the programming capabilities that are accessedinfrequently are kept in the Setup menus. The external infusion device10 has two layers of setup menus, Setup I and Setup II. Setup I containscapabilities that are used more often than those in Setup II. Both SetupI and Setup II menus will be accessible through the main menu bypressing the SEL key 114 at the links between the Setup I and Setup II(see FIGS. 6-12). The Setup I menu (see FIGS. 10 and 12) will be enteredby pressing the ACT key 110, while the Setup I screen is beingdisplayed. While in the Setup I menu, the screens that are displayed areTime Adjustment, Automatic Off Duration, Beep Volume, User Self Test,Setup II and Setup Exit. The Setup II menu (see FIGS. 9 and 11) can beentered by pressing the ACT key 110 while the Setup II screen is beingdisplayed. While in the Setup II menu, the screens that are displayedare Audio Enhanced Bolus Mode On/Off & Increment, Variable Boluses ModeOn/Off, Bolus Estimator (carbohydrate calculator), Maximum Bolus,Maximum Basal rate, Time Mode (12/24 hour display), InsulinConcentration, Alarm Review, Alarm Mode, Child-lock (lock-out), Set RFDevice, Personal Delivery Patterns, Setup I and Setup Exit.

[0148] Generally, none of the values can be changed directly from theSelect States. To alter a value on an informative display, the user mustfirst press the ACT key 110. This is referred to as entering a SetState. The word “SET” will appear on the display (and/or an audibleand/or vibration indication is provided), and the value that can bechanged will be blinking. Pressing the Up arrow key (▴) 108 or the Downarrow key (▾) 112 will change the blinking value. After scrolling to thedesired value, the ACT key 110 must be pressed again. This will activatethe new value and return the external infusion device 10 to the normaloperating (time) display. If more than one value can be changed on asingle display, pressing the ACT key 110 will cause the other value tobe selected and the Up arrow key (▴) 108 and the Down arrow key (▾) 112will affect this next value. Two general exceptions to the preferredrule governing the parameter selection described above are the normaloperating (time) display and the Total History state. Both are SelectStates. When the normal operating (time) display is in effect, pressingthe ACT key 110 will show the user the amount of battery power left, or,alternatively, or in addition to, the amount of medication remaining inthe reservoir (thus time cannot be changed from it, since time settingis handled in the Setup I menu). The Total History state is forinformation only. Historical total values may be viewed directly fromthe select state with the arrow keys.

[0149] In preferred embodiments, if the external infusion device 10 isleft idle while in a Set State, the software will return to the timedisplay state after approximately 15 seconds, no changed values will beactivated. If the external infusion device 10 is left idle in a SelectState, it will return to the time display state in approximately 7seconds. In alternative embodiments, longer or shorter time periods forthe various states may be used.

[0150] The external infusion device 10 will preferably include thefollowing Select States in the main menu (see FIGS. 9 and 11): timedisplay, bolus history, suspend, basal rate, temporary basal rate, totalhistory, prime bolus, Setup I menu and Setup II menu. The Setup I menu(see FIGS. 10 and 12) will feature the additional select states: timeand date adjustment, automatic off duration, beep volume, user selftest, Setup II, and Setup exit. The Setup II menu (see FIGS. 6 and 8)will feature the following options: audio enhanced bolus modeenable/disable & increment, variable bolus mode enable/disable, maximumbolus, maximum basal rate, bolus estimator setting, personal deliverypattern selection, alarm clock setting, insulin concentration, alarmreview, lock-out, RF programmer set up, Setup I, and Setup exit. After acapability is activated in any Set State in the normal operating menu,the normal operating display (time display) will be displayed. Inalternative embodiments, other values may be displayed.

[0151] Preferably, after a capability is activated in one of the Setupmenus, the next Setup Select State will be displayed. Once in one of theSetup Menus, the user may use the SEL key 114 to view all of the SetupSelect States until the keyboard is allowed to time out (inapproximately 15 seconds) or the user presses the ACT key 110 on theExit Setup state.

[0152] Preferably, the SEL key 114 is used to select an option. Forsafety, using this key will never change any value. If there is morethan one option in a single programming sequence (Set State), such ashours, minutes, and date on the time setting display, the options areselected with the ACT key 110. The ACT key 110 is used to allow changingof values by entering set states, and to activate changed values. The Uparrow key (▴) 108 and the Down arrow key (▾) 112 are available as validkeys when numbers or dashes are blinking. However, in preferredembodiments, there are two exceptions: while normal operating (time)screen is displayed, 1) pressing the Up arrow key (▴) 108 invokes theaudio enhanced bolus function if enabled in setup II; and 2) pressingthe Down arrow key (▾) 112 turns on the LCD backlighting. The backlightwill remain on for about fifteen seconds after the last key press. Anykey press before the expiration of fifteen seconds will restart thefifteen second time-out.

[0153] The external infusion device 10 can be programmed to deliver upto forty-eight basal rates daily. The user does not need to program allforty-eight rates. The multiple basal rates are called profile segments.Profile segments are preferably programmed with a start time and a basalrate. A profile segment rate will become active at the profile segmentstart time. This allows for several different delivery schedules tooccur without requiring the user to reprogram the external infusiondevice 10. The first profile segment always begins at midnight. Theother profile segments always start on even hour or half-hourboundaries. The delivery pattern will repeat daily. In alternativeembodiments, the external infusion device 10 may contain more, or less,than forty eight profiles, with amount being dependent on memory, timeincrement for each profile, and the like.

[0154] A Setup option will allow the user access to three “personalpatterns.” in order to accommodate individual lifestyle requirements.The first personal pattern is the current basal profile pattern. Thesecond personal pattern will follow the first personal pattern and a “2”icon will be displayed by the external infusion device at all times, onthe main screen and the basal screen. The third pattern will follow thesecond pattern and display a “3” icon at all times. The patterns will bepresented to the user in a circular manner until the user selects(lashes as the time for the next basal rate. The user will choose theirpersonal pattern by selecting a 1, 2, or 3 in the setup II menu. Theuser will know which pattern is current by looking for either a blank(i.e., pattern 1 is on), a “2” icon (i.e., pattern 2 is on), or a “3”icon (i.e., pattern 3 is on).

[0155] Preferably, the user, or healthcare professional, may program twoseparate limits into the external infusion device 10. A maximum mealbolus can be set to limit the size of meal boluses. When setting a mealbolus the software will not allow the scrolling to exceed the maximum.There is also a maximum basal rate that limits the rate of profilesegments and the temporary basal rate. When setting profile segmentrates or a temporary basal rate, the software will not allow any valuesgreater than the maximum basal rate.

[0156] The meal bolus history function will allow the user to view thelast twelve meal boluses in reverse-chronological order. The Up arrowkey (▴) 108 and the Down arrow key (▾) 112 are valid from the SelectState. The most recently delivered bolus will be displayed as bolushistory 1. Older boluses will be histories 2 through 24. The display ofthe most recent bolus will show the word “LAST.” The display of theolder boluses will show the day of the week that they were delivered.for safety reasons, the historical meal boluses may not be changed.

[0157] The external infusion device 10 will maintain a history of thedaily totals for the last 90 days. The user can only display the last 7days through the pump's display, (generally 90 days are accessible bydownloading only—although other numbers of days may be used). Thisdisplay is accessed as a Select State. The day for the total may bescrolled to view total history directly from the display state. Thetotal delivered Select State will have the day (displayed as “TODAY” fortoday's date or DayMonthYear [01SEP97] for any other clay) blinking.When the day is scrolled, the display shows the corresponding day'stotal.

[0158] The user will be able to review the last 200 events that occurredto the pump. Generally. these may be reviewed on the LCD 28 of theexternal infusion device 10. Alternatively, the events are onlyavailable by downloading the data through the transmitter/receiver 26(for example using IR serial communication ) of the external infusiondevice 10. Typical types of events that can be received or downloadedare: time adjustment; auto-off duration; maximum bolus; maximum basalrate; insulin concentration; suspend on; suspend off; basal rateprofile; temp. basal rate; battery removal and battery replacement. andcarbohydrate estimator stored set values and history. The externalinfusion device 10 may be capable of communicating via itsbi-directional telemetry. It will be capable of sending data andreceiving and executing commands according to a well-defined protocol.

[0159] The LCD 28 of the external infusion device 10 introduces thecapability to use icons for easier identification and use. For example,the following icons are available: a clock alarm icon, a low batteryalarm icon, a low insulin alarm icon, and one or more personal patternicons. In alternative embodiments, more or fewer icons may be used. Theuse of icons makes an understanding of the display and alarm conditionseasier, thus increasing safety and efficient use of the externalinfusion device 10.

[0160] Alarms will be easily recognizable while providing the user withthe information they need to make an informed decision. The alarms maybe displayed on the LCD 28, provided audibly through the speaker 30and/or using the vibration alarm 16. An alert will sound when theplunger reaches the point where approximately 20 units of insulin(U-100) remain. In alternative embodiments, more or fewer remainingunits may be used, and/or the units remaining may be programmable by theuser or healthcare professional. An icon indicating “Low Volume” willappear on the main screen, and/or other alarms may be provided, untilthe condition is corrected.

[0161] Preferred embodiments will include an alarm clock. The user willdetermine and set an amount of time, preferably from 30 minutes to 24hours, although longer or shorter periods may be set. The externalinfusion device 10 unit will provide an alarm and will prompt the userto repeat the same alarm frequency or cancel the alarm. The alarm willassist in warning the user on when to test blood glucose levels, injectinsulin or the like. Alternative embodiments may include multiple alarmsand different tones to permit more precise control and monitoring.

[0162] In preferred embodiments, all alarms will gradually escalate infrequency or volume so that the user can terminate them as soon as theyare noticed. In alternative embodiments, the alarms may change tones orintermittently stop to draw attention to the alarm condition. In fartheralternatives, the external infusion device 10 may use thetransmitter/receiver 26 to transmit the alarm to a remotely locateddevice, such as a Communication-Station, modem or the like to summonhelp.

[0163] In preferred embodiments, there is also a maximum number ofexternal infusion device 10 strokes for the drive mechanism 32 that mayoccur in one hour based on the maximum basal rate and bolus amounts. Theexternal infusion device 10 will sound (or vibrate) and the externalinfusion device 10 will not be able to deliver more than ((2.5*maximumbolus)+maximum basal+1) strokes in one hour. Preferably, the externalinfusion device 10 will deliver medication in 0.1 units volumeincrements (although other increments may be used). The actual amount ofinsulin or medication in a given stroke depends on the insulin ormedication concentration, stroke length and delivery reservoir diameteror cross-sectional area. In preferred embodiments, the delivery ratesare scrolled by the amount of insulin per stroke. The rate deliverypattern will be calculated by dividing the number of strokes requiredfor the rate into 3600 (the number of seconds in one hour). The resultis the number of seconds between each stroke. The rate will be deliveredevenly over the hour, each stroke on a one-second boundary. Rates thatdo not divide evenly into 3600 will not have any accumulating error. Forexample, consider a rate of 3.0 units per hour and a concentration ofU-100. 3.0 U/hr at U-100 will require 30 strokes per hour. Thistranslates to a pump stroke every 3600/30=120 seconds, or one strokeevery two minutes. In alternative embodiments, the drive mechanism 32may provide for continuous flow rather than incremental or pulsed flowrates. Further alternatives may omit strokes and utilize hydraulics,pneumatics, step motors, continuous motors, or the like.

[0164] The external infusion device 10 will support drug delivery inU-400, U-250, U-200, U-100, U-50 and U-40 concentrations of insulin. Inalternative embodiments, the external infusion device 10 will supportdrug delivery in insulin concentrations below U-40 and above U-400, suchas U-500 and U-1000. The amount of insulin delivered per pump strokedepends upon the concentration. If the concentration is changed, theconstant factors which convert pump strokes into units of insulin arechanged accordingly. Preferably, when a new concentration is selected,all settings except the time of day and day of week return to thefactory default settings. The default concentration is U-100. Inalternative embodiments, different default concentrations may be setbeing dependent on the type of fluid to be infused, and different or nosettings will return to the factory defaults. Preferred embodiments ofthe external infusion device 10 will utilize a conventional plastic(such as the MiniMed MMT-103) reservoir. Alternative embodiments may usereservoirs formed out of other materials, such as glass, metal or thelike; and the reservoir may be pre-filled or filled by the user prior touse in the external infusion device 10.

[0165] Preferred embodiments of the external infusion device 10 can bedropped in water without causing damage to the pump. (IEC601-1 IPX7watertight standard—although other levels of water resistance orstandards may be used). The external infusion device 10 may be resilientto being dropped, such as withstanding a 1500 g force with a 0.5 msechalf-sine pulse duration (although other levels of impact resistance maybe used). The infusion pump 10 will not be damaged by normal chemicalsit may encounter: soap, insulin, suntan lotion, alcohol, betadine, Cometcleanser, 409 cleaner, Windex, Joy dish soap, 25% bleach mixture.

[0166] Preferred embodiments will utilize a cylindrical Li/MnO₂ primarybattery. Part Number Manufacturer PX28L (1406LC NEDA/ANSI: IEC) Duracell

[0167] Alternative embodiments may use multiple batteries, or batterieshaving different chemical compositions or characteristics. For instance,embodiments may use silver-oxide based batteries, such as Energizer 357batteries, mercury oxide. or other lithium chemistries. Furtherembodiments may include rechargeable batteries using either a DCpowerport, induction, solar cells, or the like, for recharging.

[0168] Preferably, the external infusion device 10 will report a lowbattery condition at a battery voltage of 4.2 volts with a 1.0 milliampload. The absolute maximum current that may be delivered by the batterywill be less than 60 milliamps for a maximum of 10 seconds. To maximizebattery life, each delivery of 0.1 unit of insulin will consume lessthan 0.025 millijoules of battery energy. The average continuous batterycurrent will not exceed 65 μA, excluding charging for insulin delivery.Preferably, the external infusion device 10 will indicate relativebattery longevity. This information can be conveyed in a concept similarto a cellular phone's battery status indicator. FIG. 13 illustratesexpected battery performance in days of operation versus units ofmedication delivered.

[0169]FIG. 14 illustrates a table of typical factory default values usedby an external infusion device 10. Alternative embodiments, may useother default values with the selection being dependent on the types ofmedication or fluid to be infused.

[0170] While the description above refers to particular embodiments ofthe present invention, it will be understood that many modifications maybe made without departing from the spirit thereof. The accompanyingclaims are intended to cover such modifications as would fall within thetrue scope and spirit of the present invention.

[0171] The presently disclosed-embodiments are therefore to beconsidered in all respects as illustrative and not restrictive, thescope of the invention being indicated by the appended claims, ratherthan the foregoing description, and all changes which come within themeaning and range of equivalency of the claims are therefore intended tobe embraced therein.

What is claimed is:
 1. An external infusion device for infusion of aliquid into a body, the external infusion device comprising: a housing;a receiver coupled to the housing for receiving remotely generatedcommands; a processor coupled to the housing and the receiver to receiveremotely generated commands and to control the external infusion devicein accordance with the commands; and an indication device to indicatewhen a command has been received and indicate when the command is beingutilized to control the external infusion device such that the externalinfusion device is capable of being concealed from view when beingremotely commanded.
 2. An external infusion device according to claim 1,wherein the external infusion device includes a memory for storingprograms, and wherein the receiver is capable of receiving softwareupdates and facilitating remote programming of external infusion devicecapabilities.
 3. An external infusion device according to claim 1,wherein the external infusion device includes a memory for storing apatient infusion history and pump activity.
 4. An external infusiondevice according to claim 1, wherein the remotely generated commands arecapable of programming and activating an audio bolus delivery of theliquid by the external infusion device.
 5. An external infusion deviceaccording to claim 1, wherein the remotely generated commands arecapable of programming and activating a vibration bolus delivery of theliquid by the external infusion device.
 6. An external infusion deviceaccording to claim 1, wherein the remotely generated commands arecapable of programming and activating a temporary basal rate delivery ofthe liquid by the external infusion device.
 7. An external infusiondevice according to claim 1 wherein the remotely generated commands arecapable of programming and suspending delivery of the liquid by theexternal infusion device.
 8. An external infusion device according toclaim 1 wherein the remotely generated commands are capable ofprogramming and activating an extended bolus delivery of the liquid bythe external infusion device.
 9. An external infusion device accordingto claim 1, wherein the remotely generated commands are capable ofprogramming and activating a dual wave bolus delivery of the liquid bythe external infusion device.
 10. An external infusion device accordingto claim 1, wherein the remotely generated commands are capable ofprogramming and activating a profiled bolus delivery of the liquid bythe external infusion device.
 11. An infusion system for infusing aliquid into a body, the infusion system comprising: an external infusiondevice including: a housing; a receiver coupled to the housing and forreceiving remotely generated commands; a processor coupled to thehousing and the receiver to receive remotely generated commands and tocontrol the external infusion device in accordance with the commands;and an indication device to indicate when a command has been receivedand indicate when the command is being utilized to control the externalinfusion device such that the external infusion device is capable ofbeing concealed when being remotely commanded; and a remote commanderincluding: a commander housing; a keypad coupled to the commanderhousing for inputting commands; and a transmitter coupled to the keypadfor transmitting commands to the receiver of the external infusiondevice.
 12. An infusion system according to claim 11, wherein theexternal infusion device further includes a device transmitter to verifyreceipt of commands from the remote commander, wherein the remotecommander further includes a remote receiver to receive the verificationfrom the device transmitter of the external infusion device, and whereinthe remote commander further includes a remote indication device toindicate receipt of the verification from the external infusion device.13. An infusion system according to claim 11, wherein the remotecommander is sized to fit on a key ring.
 14. An infusion systemaccording to claim 11, wherein the remote commander uses RF frequenciesto transmit remote commands to the external infusion device.
 15. Aninfusion system according to claim 11 wherein the remote commander usesIR frequencies to transmit remote commands to the external infusiondevice.
 16. An infusion system according to claim 11, wherein the remotecommander uses optical frequencies to transmit remote commands to theexternal infusion device.
 17. An infusion system according to claim 11,wherein the remote commander uses ultrasonic frequencies to transmitremote commands to the external infusion device.
 18. An infusion systemaccording to claim 11, wherein the remote commander uses audiofrequencies to transmit remote commands to the external infusion device.19. An infusion system according to claim 11, wherein the remotecommander uses magnetic effects to transmit remote commands to theexternal infusion device.
 20. An infusion system according to claim 11,wherein the remote commander is capable of providing remote commands ata distance greater than 1 inch.
 21. An infusion system according toclaim 11, wherein the processor of the external infusion device has aunique identification code, and wherein the remote commander includesthe capability to read and learn the unique identification code of theexternal infusion device, and wherein the remote commander and theexternal infusion device use the unique identification code tosubstantially avoid interference with other external infusion devices.22. An infusion system according to claim 11, wherein the remotecommander has a unique identification code, and wherein the processor ofthe external infusion device includes the capability to read and learnthe unique identification code of the remote commander, and wherein theremote commander and the external infusion device use the uniqueidentification code to substantially avoid interference with otherremote commanders.
 23. An infusion system according to claim 11, whereinthe remote commander includes a mode that permits physician controlledprogramming of specific capabilities of the external infusion device tothe exclusion of the user.
 24. An infusion system according to claim 11,wherein the remote commander may also include a link to a computer toallow computer programming to initiate or alter available capabilitiesof the external infusion device.
 25. An infusion system according toclaim 11, wherein the external infusion device includes a memory forstoring programs, and wherein the receiver is capable of receivingsoftware updates to facilitate remote programming of external infusiondevice capabilities.
 26. An infusion system according to claim 11,wherein the remote commander is capable of receiving data from anothermedical device and relaying the received data to the external infusiondevice.
 27. An infusion system according to claim 26, wherein the remotecommander is capable of remotely commanding and controlling the othermedical device.
 28. An infusion system according to claim 11, whereinthe remote commander is capable of programming and activating an audiobolus delivery of the liquid by the external infusion device.
 29. Aninfusion system according to claim 11, wherein the remote commander iscapable of programming and activating a vibration bolus delivery of theliquid by the external infusion device.
 30. An infusion system accordingto claim 11, wherein the remote commander is capable of programming andactivating a temporary basal rate delivery of the liquid by the externalinfusion device.
 31. An infusion system according to claim 11, whereinthe remote commander is capable of programming and suspending deliveryof the liquid by the external infusion device.
 32. An infusion systemaccording to claim 11, wherein the remote commander is capable ofprogramming and activating an extended bolus delivery of the liquid bythe external infusion device.
 33. An infusion system according to claim11, wherein the remote commander is capable of programming andactivating a profiled bolus delivery of the liquid by the externalinfusion device.
 34. An infusion system according to claim 11, whereinthe remote commander is capable of programming and activating a dualwave bolus delivery of the liquid by the external infusion device. 35.An external infusion device for infusion of a liquid into a body, theexternal infusion device comprising: a housing; a processor coupled tothe housing; a bolus estimator used in conjunction with the processorand externally supplied values to estimate all amount of liquid to beinfused based upon an estimate of a material to be taken in by the body;and an indication device to indicate when an amount of fluid to beinfused has been calculated.
 36. An external infusion device accordingto claim 35, wherein the bolus estimator includes the capability tocalculate a correction bolus based upon a current characteristic valueand a target characteristic value.
 37. An external infusion deviceaccording to claim 36, wherein the bolus estimator includes a liquidsensitivity that is used to determine the amount of liquid to be infusedto calculate the correction bolus.
 38. An external infusion deviceaccording to claim 37, wherein the liquid to be infused is insulin, andwhere the material to be taken in are carbohydrates.
 39. An externalinfusion device according to claim 35, wherein the liquid to be infusedis insulin, and where the material to be taken in are carbohydrates. 40.An external infusion device according to claim 35, wherein the bolusestimator includes a lockout to prevent the calculation of a bolus for apredetermined period of time after a bolus estimated by the bolusestimator.
 41. An external infusion device according to claim 35,wherein the supplied values are codes representing a carbohydrate valueof specific foods.
 42. An external infusion device according to claim35, wherein the supplied values are codes representing a carbohydratevalue of specific meals.
 43. An external infusion device according toclaim 35, further including a duration factor to determine a value ofhow long a previously infused amount of liquid will remain active in thebody, wherein the determined value is used to adjust the amount of thefluid to be infused.
 44. An external infusion device for infusion of aliquid into a body, the external infusion device comprising: a housingcontaining a reservoir; a processor coupled to the housing; and avibration alarm used in conjunction with the processor to provide analarm, and to generate sufficient vibration to assist in removing gasbubbles from the fluid in the reservoir during priming of the externalinfusion device.
 45. An external infusion device according to claim 44,wherein the vibration alarm is used to agitate the fluid in thereservoir in between successive delivery periods of the fluid by theexternal infusion device.
 46. An external infusion device according toclaim 44, wherein the vibration alarm is used to agitate the fluid inthe reservoir during delivery of the fluid by the external infusiondevice.
 47. An external infusion device for infusion of a liquid into abody, the external infusion device comprising: a housing containing areservoir; a processor coupled to the housing; an audible alarm coupledto the processor; and a vibration alarm used in conjunction with theprocessor and the audible alarm to provide an alarm.
 48. An externalinfusion device according to claim 47, wherein the vibration alarm isalso used to agitate the fluid in the reservoir in between successivedelivery periods of the fluid by the external infusion device.
 49. Anexternal infusion device according to claim 47, wherein the vibrationalarm is also used to agitate the fluid in the reservoir during deliveryof the fluid by the external infusion device.
 50. An external infusiondevice according to claim 47, wherein the processor selects to activateone of the audible alarm and vibration alarm independently of theunselected alarm.
 51. An external infusion device for infusion of aliquid into a body, the external infusion device comprising: a housing;a processor coupled to the housing; a keypad coupled to the housing andused in conjunction with the processor to determine an estimate ofremaining battery power; and an indication device to indicate theestimate of remaining battery power.
 52. An external infusion device forinfusion of a liquid into a body, the external infusion devicecomprising: housing; a processor coupled to the housing; a memorycoupled to and used in conjunction with the processor to store at leasttwo personal delivery patterns; a keypad coupled to the housing and usedin conjunction with the processor to select one of the at least twopersonal delivery patterns; and an indication device to indicate theselected personal delivery pattern, wherein the processor controls theexternal infusion device in accordance with the selected one of the atleast two personal delivery patterns.
 53. An external infusion devicefor infusion of a liquid into a body, the external infusion devicecomprising: a housing; a receiver coupled to the housing for receivingremotely generated commands; a processor coupled to the housing; amemory coupled to and used in conjunction with the processor to store atleast two personal delivery patterns, wherein the processor is coupledto the receiver to receive the remotely generated commands and tocontrol the external infusion device in accordance with the commands toselect one of the at least two personal delivery patterns; and anindication device to indicate the selected personal delivery pattern andwhen a command has been received to control the external infusion devicein accordance with the selected personal delivery pattern such that theexternal infusion device is capable of being concealed from view whenbeing remotely commanded, wherein the processor controls the externalinfusion device in accordance with the selected one of the at least twopersonal delivery patterns.
 54. An external infusion device for infusionof a liquid into a body the external infusion device comprising: ahousing; a processor coupled to the housing; a memory coupled to andused in conjunction with the processor to store at least two basal rateprofiles; a keypad coupled to the housing and used in conjunction withthe processor to program the at least two basal rate profiles; and anindication device to indicate the basal rate profiles duringprogramming, wherein the processor controls the external infusion devicein accordance with the programmed at least two basal rate profiles. 55.An external infusion device for infusion of a liquid into a body, theexternal infusion device comprising: a housing; a processor coupled tothe housing; a memory coupled to and used in conjunction with theprocessor to store at least two bolus types; a keypad coupled to thehousing and used in conjunction with the processor to select one of theat least two bolus types; and an indication device to indicate theselected bolus type, wherein the processor controls the externalinfusion device in accordance with the selected one of the at least twobolus types.